Posted by Michael Wonder on 26 Jul 2025
Gilead receives positive CHMP opinions under accelerated review from EMA for twice yearly lenacapavir for HIV prevention
25 July 2025 - Positive opinion also received for EMA’s EU-M4all Procedure, designed to facilitate availability in low- and lower-middle-income countries.
Gilead Sciences today announced that the CHMP of the EMA adopted a positive opinion under accelerated review recommending lenacapavir—the company’s injectable HIV-1 capsid inhibitor—for use as pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk.
